Firesorb™ Granted Green Channel Status for CFDA Approval

Shanghai, China - Firesorb™ Bioresorbable Rapamycin Target Eluting Coronary Scaffold System ("Firesorb™"), the second-generation fully bioresorbable scaffold in-house developed by Shanghai MicroPort Medical (Group) Co ("MicroPort®"), was recently granted by China Food and Drug Administration ("CFDA") the Green Channel status, a special fast-track procedure for innovative medical devices to gain CFDA approval. This will significantly shorten the approval time, and MicroPort® is expected to provide a better solution of bioresorbable scaffold to domestic patients with coronary heart diseases in the near future.
 
As the second-generation fully bioresorbable scaffold, Firesorb™ features thinner strut which could lower the crossing profile, shorten the bio-degradation time, so as to reduce the risk of postoperative thrombosis. In Firesorb™'s target-eluting design, the drug only retains on one surface that contacts blood vessels, with 60% less drug loadings compared to similar products. Such design reduces the dose of drug, enhances the efficiency of the treatment, and prevents a large amount of drug residual from remaining in the body for a long time, while achieving the same clinical efficacy as other bioresorbable scaffolds.
 
MicroPort® has completed the patient enrollment for FUTURE-I, the perspective, single group observation, First-in-Man ("FIM") clinical trial of evaluating the safety and efficacy of Firesorb™ in the treatment of coronary heart diseases, with related studies running smoothly.